sartoriusstedim biotech Flexsafe Pro Mixer Pre-designed Solutions The Fast, Flexible and Intelligent Single-Use Mixer for All Mixing Steps in cGMP Bioprocessing turning science

Please click on the headline to go to the selected topic   Please click on the box that matches your process need pH sensor & Thermowell* A Fast, Flexible and Intelligent Solution From 50 L up to 3,000 L . . . 3 Media Formulation Assurance of Supply for All Fluid-contact Components . . . . . . . . . . . 5 Validation and Quality Assurance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 The Fast, Flexible and Intelligent Solution for All Mixing Steps in cGMP Bioprocessing . . . . . . . . . . . . . . . . . . . . 7 One Unique Mixing Solution for All Mixing Steps in cGMP Bioprocessing...

Flexsafe® Pro Mixer Pre-designed Solutions Downstream Intermediates Drug Substance Drug Product Back to Table of Contents A Fast, Flexible and Intelligent Solution From 50 L up to 3,000 L Building on 20 years of experience in designing single-use fluid management solutions, we have established Pre-designed Solutions (PDS) for all process steps where either powerful or low shear mixing performances are required. Flexsafe® Pro Mixer technology combines speed and efficiency to deliver high performance mixing during powder dissolution and a levitating impeller to preserve the drug during low shear...

Downstream Intermediates Flexsafe® Pro Mixer Pre-designed Solutions Drug Substance Drug Product Back to Table of Contents A Fast, Flexible and Intelligent Solution from 50 L up to 3,000 L Drug Substance Purification Pre-designed Solutions for drug substance purification Buffer Formulation Pre-designed Solutions for buffer formulation Downstream Intermediates Pre-designed Solutions for downstream intermediates Drug Product Formulation Pre-designed Solutions for drug product formulation

Downstream Intermediates Flexsafe® Pro Mixer Pre-designed Solutions Drug Substance Drug Product Back to Table of Contents Assurance of Supply for All Fluid-contact Components Component Quality and Change Control Fluid-contact components used for Flexsafe Pro Mixer PDS are secured by long term contracts and quality agreements to offer the best assurance of supply. Our supply contracts and quality agreements ensure at least a 24-month change notification on fluid-contact components thus providing robust change control and business continuity. Fluid-contact components are also available off-the-shelf...

Downstream Intermediates Flexsafe® Pro Mixer Pre-designed Solutions Flexsafe® Pro Mixer PDS are qualified against extensive biological, chemical, physical, extractable and functional testing. Sartorius Stedim Biotech Quality Systems for single-use products follow applicable ISO 9001 standard. Design, manufacture, quality control and sterilization of PDS are conducted under conditions that mirror biopharmaceutical operations and meet cGMP like requirements to ensure they are supplied clean, pure, non-pyrogenic fluid path and sterile . PDS are validated and routinely controlled to provide consistent...

Flexsafe® Pro Mixer Pre-designed Solutions Downstream Intermediates Drug Substance Drug Product Back to Table of Contents The Fast, Flexible and Intelligent Solution for All Mixing Steps in cGMP Bioprocessing Flexible and Ergonomic Design The Flexible and Ergonomic Design of the Flexsafe® Pro Mixer 50 – 3,000 L Offers Ease of Use: The Flexsafe® Pro Mixer Bag (50 –1,000 L) contains a central magnetic impeller assembly. Its unique sided K-weld design simplifies installation and facilitates the unfolding and folding of the bag during filling and draining operations. The 8” diameter top port allows...

Flexsafe® Pro Mixer Pre-designed Solutions Downstream Intermediates Drug Substance Drug Product Back to Table of Contents One Unique Mixing Solution for All Mixing Steps in cGMP Bioprocessing Top lines Large 8’’ diameter Top Port • H adjustment lines with CPC Quick coupler p or Opta® SFT female • pened Top Port for powder O transfer • losed Top Port for sterile or low C bioburden application or when using drain valves on the bottom lines: • top addition lines with CPC Quick coupler or Opta® SFT female • and | or sampling line with clave needleless sampling port Single-Use Sensors for in line...

Downstream Intermediates Flexsafe® Pro Mixer Pre-designed Solutions for Drug Substance Drug Product Back to Table of Contents Media Formulation pH sensor & Thermowell Thermowell No sensor Flexsafe® Pro Mixer technology combines speed and efficiency to deliver high performance mixing during powder dissolution such as media powder. An optimized media formulation process involves filling the mixer with water for injection (WFI) up to 60% to 80% of the final volume. WFI can be heated up with the heat exchange jacket to accelerate the dissolution. The mixing drive unit is started and the media powder...

Downstream Intermediates Flexsafe® Pro Mixer Pre-designed Solutions for Drug Substance Drug Product Back to Table of Contents Intelligent Flexsafe® Pro Mixer Bag with pH Sensor & Thermowell Opened 8” Top Port with gasket, cap & union Top Port Inlet Outlet Sampling Addition 1 Addition 2 pH Adjustment a” ID TuFlux® Silicone 1,5 m (60”) + a” Tri-Clamp 1a” sanitary flange with gasket, cap & union a” ID TuFlux® Silicone 1,5 m (60”) + a” Tri-Clamp 1a” sanitary flange with gasket, cap & union When drain valves: 1 top line: %" ID TuFlux® Silicone 0 15 m (6”) + MPC Female + sealing cap When no drain valve:...

Downstream Intermediates Flexsafe® Pro Mixer Pre-designed Solutions for Drug Substance Drug Product Back to Table of Contents Intelligent Flexsafe® Pro Mixer Bag with pH Sensor & Thermowell Opened 8” Top Port with gasket, cap & union Top Port Inlet Outlet Sampling Addition 1 Addition 2 pH Adjustment 1/2” ID TuFlux® Silicone 1,5 m (60”) + /” Tri-Clamp 1/” sanitary flange with gasket, cap & union 1/2” ID TuFlux® Silicone 1,5 m (60”) + /” Tri-Clamp 1/” sanitary flange with gasket, cap & union i/4” ID TuFlux® Silicone 0 .1 m (4”) + Clave needleless sampling port When drain valves: 1 bottom line:...